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Completed

NCT Number: NCT05820139

Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

Urinary retention can lead to bladder over-distention, ischemia, and long-term voiding dysfunction, and early identification of urinary retention can help prevent these adverse events

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Key information

Conditions

Voiding Dysfunction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Infections Lower Urinary Tract Symptoms Male Urogenital Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Urinary Bladder Diseases Urinary Bladder, Overactive Urinary Tract Infections Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157, United States

About this study

Postoperative voiding trials (VT) can identify as well as prevent postoperative urinary retention. Voiding trial protocols vary by provider and healthcare facilities/institutions as there is no consensus on how to prevent postoperative urinary retention optimally. Identification of an optimal VT could not only help decrease adverse events associated with urinary retention but also decrease postoperative catheter-associated urinary tract infection (CAUTI) rates, unplanned hospital or clinic visits, and decrease patient discomfort while increasing patient satisfaction.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Nonpregnant women >18yo undergoing pelvic organ prolapse or urinary incontinence surgery

Exclusion criteria

  • Patients undergoing fistula repair or sacral neuromodulation
  • Voiding dysfunction preoperatively that requires intermittent self-catheterization
  • Intraoperative bladder injury
  • Pregnancy
  • Preoperative UTI (culture proven within 7 days prior to surgery)

Treatment and study plan

Control Group

Procedure

Patients will be randomized to a 200mL (control group)

Other names: backfill-assisted voiding trial

Test Group

Procedure

Patients will be randomized to a cut-off of 150mL (test group)

Other names: backfill-assisted voiding trial

Primary outcomes

  1. difference in acute voiding dysfunction between a backfill assisted voiding trial

    Time frame: Week 6

    difference in acute voiding dysfunction between a backfill assisted voiding trial with a volume voided cutoff of 150mL vs. 200mL for passage of VT - Acute voiding dysfunction is defined as a failed voiding trial requiring discharge home with a catheter, as well as voiding dysfunction occurring at a later time that results in an emergency department/urgent care/clinic visit requiring either an indwelling catheter or clean intermittent catheterization (CIC)

Secondary outcomes

  1. proportion of patients develops postoperative UTIs

    Time frame: Day 7

    UTI diagnosed by symptomatology alone or urinalysis (UA) + culture proven within one week (7 days) of catheter removal

  2. proportion of patients developing overactive bladder symptoms

    Time frame: Week 6

    Sudden urge to urinate that is difficult to hold, with leakage of urine (even if you just voided recently), Frequent urination (>8 times/day), or waking up at night to urinate (2 or more times/night)

  3. proportion of patients developing bladder pain or pressure

    Time frame: Week 6

    Bladder pain (pain or discomfort in the lower abdomen when your bladder is full) or bladder pressure (continuous feeling of pressure, not relieved by urination)

  4. proportion of patients requiring repeat outpatient voiding trials

    Time frame: Week 6

    proportion of patients requiring repeat outpatient voiding trials

  5. average number of days postoperatively, that require catheterization

    Time frame: Week 6

    average number of days postoperatively, that require catheterization

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Randomized Controlled Single-Blinded Study Evaluating the Optimal Volume Voided for Passage of a Backfill-Assisted Voiding Trial Following Urogynecologic Surgery

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 19, 2023
Registry last updated
Apr 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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